Biopsy device with aspiration valve

ABSTRACT

A biopsy device includes an instrument set and an instrument drive unit removably coupled to the instrument set. The instrument set includes an instrument set housing; an elongate outer cannula having a tissue receiving aperture in a side wall thereof; an elongate inner cannula disposed within an outer cannula lumen; an aspiration vent fluidly coupling the outer cannula lumen to atmosphere; and an aspirate valve in the aspiration vent, and configured such that the outer cannula lumen is vented to atmosphere only when the aspirate valve is open. The instrument drive unit includes a drive unit support structure removably coupled to the instrument set housing; a motorized inner cannula driver configured to axially oscillate the inner cannula relative to the outer cannula to sever tissue extending through the tissue receiving opening; and an actuating member configured to selectively mechanically prevent the aspirate valve from closing.

RELATED APPLICATION DATA

The present application is a continuation of U.S. patent applicationSer. No. 15/828,136, filed Nov. 30, 2017, which is a continuation ofU.S. patent application Ser. No. 15/024,631, filed Mar. 24, 2016, nowU.S. Pat. No. 9,844,363, which is a National Phase entry under 35 U.S.C§ 371 of International Patent Application No. PCT/US2015/052017, havingan international filing date of Sep. 24, 2015, which claims the benefitof priority under 35 U.S.C. § 119 to U.S. provisional patent applicationSer. No. 62/055,338, filed Sep. 25, 2014, which is hereby incorporatedby reference into the present application in its entirety.

FIELD

The present disclosure generally relates to the field of tissue samplingand harvesting. More specifically, the disclosure relates to biopsyneedle sets and devices for use therewith.

BACKGROUND

In the practice of diagnostic medicine, it is often necessary ordesirable to perform a biopsy, or to sample selected tissue from aliving patient for medical evaluation. Cytological and histologicalstudies of the biopsy sample can then be performed as an aid to thediagnosis and treatment of disease. Biopsies can be useful in diagnosingand treating various forms of cancer, as well as other diseases in whicha localized area of affected tissue can be identified.

Biopsies are routinely performed on tissue using a biopsy deviceincluding a needle set. One known needle set includes an outer cannulahaving a pointed tip and a tissue receiving opening defined near itsdistal end, and an inner cannula having an open distal end surrounded byan annular cutting blade. The inner cannula is slidably disposed withinthe outer cannula so that it can close the tissue receiving opening,thereby cutting tissue prolapsing into the lumen of the outer cannulathrough the tissue receiving opening. In vacuum-assisted biopsy devices,a vacuum is used to draw the tissue into the tissue receiving openingand to draw excised tissue through the inner cannula to a locationproximal of the inner cannula. An irrigation system may also beconnected to the outer cannula to provide liquid to facilitate thebiopsy. Liquids such as saline may facilitate the biopsy process. Theliquid may also provide therapy, such as analgesia provided by ananalgesic.

Vacuum-assisted biopsy devices are available in handheld (for use withultrasound) and stereotactic (for use with X-ray) versions. Stereotacticdevices are mounted to a stereotactic unit that locates the lesion andpositions the needle for insertion. In preparation for a prone biopsyusing a stereotactic device, the patient lies face down on a table, andthe breast protrudes from an opening in the table. The breast is thencompressed and immobilized by two mammography plates. The mammographyplates create images that are communicated in real-time to thestereotactic unit. The stereotactic unit then signals the biopsy deviceand positions the device for insertion into the lesion by the operator.In contrast, when using the handheld model, the breast is notimmobilized. Rather the patient lies on her back and the doctor uses anultrasound device to locate the lesion. The doctor must thensimultaneously operate the handheld biopsy device and the ultrasounddevice.

During vacuum-assisted biopsies, as the excised tissue advancesproximally along the lumen of the inner cannula, a vacuum can be createdbehind (i.e., distal of) the advancing tissue. At some point in theseinstances, the excised tissue can stop advancing along the length of theinner cannula because the vacuum behind the excised tissue equals thevacuum in front (i.e., proximal) of the excised tissue that isattempting to draw the excised tissue through the inner cannula.

An exemplary vacuum-assisted biopsy device is described in U.S. Pat. No.6,638,235, filed on May 23, 2001, and assigned to the same assignee asthe instant application, the contents of which are incorporated byreference as though fully set forth herein. In the biopsy devicedescribed therein, a leak path between the atmosphere and the outercannula lumen allows the portion of the portion of the inner cannulalumen distal of the excised tissue to equalize in pressure with theatmosphere. This atmospheric equalization relieves the vacuum behind theexcised tissue, and aids in drawing the tissue down the length of theinner cannula.

While the vacuum-assisted biopsy device described in U.S. Pat. No.6,638,235 is an improvement over previous biopsy devices, having twoseparate connections to the outer cannula (for irrigation andatmospheric equalization) adds to the size of the biopsy device.

SUMMARY

In accordance with one embodiment, a biopsy device includes aninstrument set and an instrument drive unit removably coupled to theinstrument set. The instrument set includes an instrument set housing.The instrument set also includes an elongate outer cannula having anaxial lumen, a proximal portion coupled to the instrument set housing,and a distal portion having a tissue receiving aperture in a side wallthereof in communication with the lumen. The instrument set furtherincludes an elongate inner cannula disposed within the outer cannulalumen. Moreover, the instrument set includes an aspiration vent fluidlycoupling the outer cannula lumen to atmosphere. In addition, theinstrument set includes an aspirate valve interposed in the aspirationvent, and configured such that, when the aspirate valve is open, theouter cannula lumen is vented to atmosphere through the aspiration vent,and when the aspirate valve is closed, the outer cannula lumen is notvented to atmosphere through the aspiration vent. The instrument driveunit includes a drive unit support structure removably coupled to theinstrument set housing. The instrument drive unit also includes amotorized inner cannula driver configured to axially oscillate the innercannula relative to the outer cannula during operation of the biopsysystem, such that an open distal end of the inner cannula moves back andforth across the tissue receiving aperture to sever tissue extendingthere through. The instrument drive unit further includes an actuatingmember configured to selectively mechanically prevent the aspirate valvefrom closing.

In one or more embodiments, the instrument set includes an interferencemember that may be selectively mechanically actuated to prevent theaspirate valve from closing, where the actuating member selectivelymechanically actuates the interference member. The actuating member mayinclude a cam that is rotatably coupled to the drive unit supportstructure, where the cam may be rotated to mechanically actuate theinterference member.

The instrument drive unit also may include a motorized cam driver havingan output operatively coupled to the cam for providing automaticrotation of the cam between a first position, in which the cam does notactuate the interference member, and a second position, in which the camactuates the interference member. The motorized cam driver may beprocessor controlled to selectively rotate the cam into and out of thefirst position depending upon a respective position and a direction oftravel of the inner cannula relative to the outer cannula.

In one or more embodiments, when the aspirate valve is open, the outercannula lumen is vented to a non-sealed interior of the instrument sethousing through the aspiration vent. The aspirate valve may beconfigured such that the aspirate valve remains closed unless theinterference member is mechanically actuated to prevent the aspiratevalve from closing. Alternatively, the aspirate valve may be configuredsuch that the aspirate valve remains open unless the vacuum is suppliedthrough the outer cannula. The aspirate valve may include a sealingmember configured to seal a valve opening when a vacuum is suppliedthrough the outer cannula.

In one or more embodiments, the drive unit support structure isconfigured for mounting to a stereotactic table adapter. The sealingmember may include a ball, and the valve chamber opening may be locatedin a lateral sidewall of the valve chamber such that, when the driveunit support structure is mounted to the adapter and the instrument sethousing is coupled to the instrument drive unit, the ball falls off thevalve chamber opening under gravitational force in the absence of avacuum source drawing the ball against the valve chamber opening. Theouter cannula may be movable relative to the instrument set housing.

In one or more embodiments, the biopsy device also includes an actuatingmember configured to mechanically actuate the interference member. Theactuating member may include a rotatable cam. The rotatable cam may beoperatively coupled to a motorized cam driver. The motorized cam drivermay be processor controlled to selectively rotate the cam into and outof a position that actuates the interference member depending upon arespective position and a direction of travel of the inner cannularelative to the outer cannula.

In accordance with another embodiment, a biopsy device includes anelongate outer cannula having a lumen and a tissue receiving aperture ina side wall thereof in communication with the lumen. The biopsy devicealso includes an elongate inner cannula disposed within the outercannula lumen, the inner cannula removably coupled to a motorizedcannula driver configured to axially oscillate the inner cannularelative to the outer cannula during operation of the biopsy device suchthat an open distal end of the inner cannula moves back and forth acrossthe tissue receiving aperture to sever tissue extending there through.The biopsy device further includes an aspiration vent fluidly couplingthe outer cannula lumen to atmosphere. Moreover, the biopsy deviceincludes an aspirate valve interposed in the aspiration vent such that,when the aspirate valve is open, the outer cannula lumen is vented toatmosphere through the aspiration vent, and when the aspirate valve isclosed, the outer cannula lumen cannot vent to atmosphere through theaspiration vent, the aspirate valve including a sealing member disposedin a valve chamber. In addition, the biopsy device includes aninterference member. The respective sealing member and valve chamber aretogether configured such that the aspirate valve remains closed unlessthe interference member is selectively mechanically actuated tointerfere with, and thereby prevent, the sealing member from sealing thevalve chamber opening.

In one or more embodiments, the device has a housing and/or othersupport structure configured for mounting to a stereotactic tableadapter. The sealing member may include a ball, and the valve chamberopening may be located in a lateral sidewall of the valve chamber suchthat, when the housing or other support structure is mounted to theadapter, the ball falls off the valve chamber opening undergravitational force in the absence of a vacuum source drawing the ballagainst the valve chamber opening. The device may also include a vacuumsource fluidly coupled to a lumen of the inner cannula such that thevacuum source is also in fluid communication with the outer cannulalumen when an open distal end of the inner cannula is in fluidcommunication with the outer cannula lumen.

In accordance with still another embodiment, a biopsy apparatus includesan instrument set configured for removable coupling with an instrumentdrive unit, the instrument set including an instrument set housing; anelongate outer cannula having an axial lumen, a proximal portion coupledto the instrument set housing, and a distal portion having a tissuereceiving aperture in a side wall thereof in communication with thelumen; an elongate inner cannula disposed within the outer cannulalumen; an aspiration vent fluidly coupling the outer cannula lumen toatmosphere; and an aspirate valve interposed in the aspiration vent, theinner cannula having a lumen in fluid communication with the tissuereceiving aperture in the outer cannula via a distal opening in theinner cannula. A method of operating the biopsy apparatus includesintroducing the distal portion of the biopsy apparatus in tissue so thatthe tissue receiving aperture in the outer cannula is positionedadjacent the tissue targeted for biopsy. The method also includesapplying vacuum though a proximal end of the inner cannula lumen. Themethod further includes translating the inner cannula relative to theouter cannula to sever tissue prolapsed into the tissue receivingopening. Moreover, the method includes translating the inner cannulaproximally relative to the outer cannula. In addition, the methodincludes opening the aspirate valve to draw air into the biopsyapparatus through the aspiration vent to relieve a vacuum formed distalof the severed tissue.

In one or more embodiments, the aspiration vent is fluidly coupled to anon-sealed interior of the instrument set housing. When the aspiratevalve is open, the outer cannula lumen may vent to the non-sealedinterior of the instrument set housing through the aspiration vent. Theinstrument set may include an interference member. The method mayinclude selectively mechanically actuating the interference member toprevent the aspirate valve from closing.

In one or more embodiments, the method also includes removably couplingthe instrument drive unit to the instrument set, where the instrumentdrive unit selectively mechanically opens the aspirate valve. Theaspirate valve may be configured such that the aspirate valve remainsopen unless the vacuum is supplied through the outer cannula. The outercannula may be movable relative to the instrument set housing.

In one or more embodiments, the instrument drive unit is removablycoupled to the instrument set, and the instrument drive unit may includean actuating member. The method may include the actuating memberselectively mechanically actuating the interference member. Theactuating member may include a cam that is rotatably coupled to a driveunit support structure, and the method may also include rotating the camto selectively mechanically actuate the interference member. Theinstrument drive unit may include a motorized cam driver having anoutput operatively coupled to the cam for providing automatic rotationof the cam between a first position, in which the cam does not actuatethe interference member, and a second position, in which the camactuates the interference member. The motorized cam driver may beprocessor controlled to selectively rotate the cam into and out of thefirst position depending upon a respective position and a direction oftravel of the inner cannula relative to the outer cannula.

In one or more embodiments, the aspirate valve is configured such thatthe aspirate valve remains closed unless the interference member ismechanically actuated to prevent the aspirate valve from closing. Theaspirate valve may include a sealing member configured to seal a valveopening when a vacuum is supplied through the outer cannula, and a valvechamber, where the sealing member is disposed in the valve chamber. Thedrive unit support structure may be configured for mounting to astereotactic table adapter. The sealing member may include a ball, andthe valve chamber opening being located in a lateral sidewall of thevalve chamber such that, when the drive unit support structure ismounted to the adapter and the instrument set housing is coupled to theinstrument drive unit. The method may include, when the vacuum isapplied though the proximal end of the inner cannula lumen, the vacuumdrawing the ball against the valve chamber opening.

In accordance with yet another embodiment, a biopsy device includes anelongate outer cannula having a lumen and a tissue receiving aperture ina side wall thereof in communication with the lumen. The biopsy devicealso includes an elongate inner cannula disposed within the outercannula lumen, the inner cannula coupled to a motorized cannula driverconfigured to axially oscillate the inner cannula relative to the outercannula during operation of the biopsy device such that an open distalend of the inner cannula moves back and forth across the tissuereceiving aperture to sever tissue extending there through. The biopsydevice further includes an aspiration vent fluidly coupling the outercannula lumen to atmosphere. Moreover, the biopsy device includes anaspirate valve interposed in the aspiration vent such that, when theaspirate valve is open, the outer cannula lumen is vented to atmospherethrough the aspiration vent, and when the aspirate valve is closed, theouter cannula lumen cannot vent to atmosphere through the aspirationvent, the aspirate valve including a sealing member disposed in a valvechamber. The respective sealing member and valve chamber are togetherconfigured such that the aspirate valve remains open unless the sealingmember is drawn to seal a valve chamber opening by a vacuum suppliedthrough the outer cannula lumen. In addition, the biopsy device includesan interference member that may be selectively mechanically actuated tointerfere with, and thereby prevent, the sealing member from sealing thevalve chamber opening.

It will be appreciated that the aspiration leak path of the biopsydevice, including the inner and outer cannulas, aspiration vent,aspirate valve and interference member, may all be located in adisposable biopsy instrument set, with the respective valve actuatingmember located in a reusable drive unit along with the inner cannuladriver.

Other and further aspects and features of embodiments of the disclosedinventions will become apparent from the ensuing detailed description inview of the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of embodiments of thedisclosed inventions, in which similar elements are referred to bycommon reference numerals. These drawings are not necessarily drawn toscale. In order to better appreciate how the above-recited and otheradvantages and objects are obtained, a more particular description ofthe embodiments will be rendered, which are illustrated in theaccompanying drawings. These drawings depict only typical embodiments ofthe disclosed inventions and are not therefore to be considered limitingof its scope.

FIG. 1 is a perspective view of a biopsy device according to oneembodiment.

FIGS. 2 and 4 are perspective views of the outer cannula of the biopsydevice depicted in FIG. 1. In FIG. 2, the cutting board is omitted forclarity.

FIG. 3 is a perspective view of the inner and outer cannulas of thebiopsy device depicted in FIG. 1. The cutting board is omitted forclarity.

FIG. 5 is a longitudinal cross-sectional view of the outer cannula ofthe biopsy device depicted in FIG. 1.

FIGS. 6 and 7 are axial cutaway views through the inner and outercannulas the biopsy device depicted in FIG. 1 at the level of the sideopenings in the outer cannula.

FIG. 8 is a perspective view of the biopsy device depicted in FIG. 1with the top housing of the disposable needle portion omitted forclarity.

FIGS. 9 to 11 are wide (FIG. 9) and detailed (FIGS. 10 and 11) bottomviews of the disposable needle portion of the biopsy device depicted inFIG. 1 with the bottom housing and adjacent components omitted forclarity. In FIGS. 10 and 11 (detailed bottom views), the biopsy devicesare in the same orientation as shown in FIG. 9 (bottom view).

FIG. 12 is a detailed perspective view of the biopsy device depicted inFIG. 1 with the top housing and adjacent components of the disposableneedle portion omitted and portions of the aspiration and irrigationsystem shown in phantom for clarity. In FIG. 12, the view is from aboveand to the left of the biopsy device with the distal end pointed to theleft of the figure, as in FIG. 1.

FIG. 13 is an axial cutaway perspective view through the biopsy devicedepicted in FIG. 1 with the top housing and adjacent components of thedisposable needle portion omitted and portions of the aspiration andirrigation system shown in phantom for clarity. The axial cutaway is atthe level of the side openings in the outer cannula. In FIG. 13, theview is from above and to the left of the biopsy device with the distalend pointed to the left of the figure, as in FIG. 1.

FIGS. 14 and 15 are bottom and perspective views of the inner and outercannulas and the aspiration and irrigation system of the biopsy devicedepicted in FIG. 1. In FIG. 15, portions of the aspiration andirrigation system are shown in phantom for clarity. In FIG. 15, the viewis from above and to the left of the biopsy device with the distal endpointed to the left of the figure, as in FIG. 1.

FIGS. 16 and 17 are detailed perspective views of the inner and outercannulas and the aspiration and irrigation system of the biopsy devicedepicted in FIG. 1, with portions shown in phantom for clarity. In FIG.16, the biopsy device has been rotated onto its left side and the viewis from the top of the device (on the left side of the figure) with thedistal end pointed to the left of the figure. In FIG. 17, the view isfrom above and to the left of the biopsy device with the distal endpointed to the left of the figure, as in FIG. 1.

FIG. 18 is an axial cutaway view through the inner and outer cannulasand the aspiration and irrigation system of the biopsy device depictedin FIG. 1, with portions shown in phantom for clarity. The axial cutawayis at the level of the side openings in the outer cannula. In FIG. 18,the view is from above and to the left of the biopsy device with thedistal end pointed to the left of the figure, as in FIG. 1.

FIGS. 19 and 20 are detailed in greater detail longitudinal cutawayviews through the inner and outer cannulas of the biopsy device depictedin FIG. 1 at the level of the side openings in the outer cannula.

FIG. 21 is a side view of the aspiration vent of the aspiration andirrigation system of the biopsy device depicted in FIG. 1, with portionsshown in phantom for clarity. In FIG. 21, the distal end of the biopsydevice is pointed to the right of the figure.

FIGS. 22 and 24 are perspective views of the biopsy device depicted inFIG. 1, with select components omitted to allow visualization of theaspiration vent of the aspiration and irrigation system and the peg ofthe actuation mechanism. In FIG. 22, other components are shown inphantom for clarity.

FIG. 23 is an axial cutaway view through the biopsy device depicted inFIG. 1, with select components omitted to allow visualization of theaspiration vent of the aspiration and irrigation system and the peg ofthe actuation mechanism.

FIGS. 25 to 28 are a series of axial cutaway view through the biopsydevice depicted in FIG. 1, with select components omitted to allowvisualization of the aspiration and irrigation system and the actuationmechanism. FIGS. 25 to 28 axially progress through the aspiration andirrigation system from proximal of the cam follower to the distal of thecam follower.

FIGS. 29 and 30 are axial and longitudinal cutaway views through theinner and outer cannulas and the aspiration and irrigation system of thebiopsy device depicted in FIG. 1, with portions shown in phantom forclarity. The axial cutaway view is at the level where the aspiration andirrigation lines join the manifold. The longitudinal cutaway view is atthe level of the outer and inner cannula lumens.

FIG. 31 is a table summarizing a biopsy procedure and that states of thecheck and aspirate valves and various irrigation and aspiration/ventingrelated functions at the respective steps in the procedure, according toone embodiment.

FIG. 32 is a system diagram schematically depicting a biopsy deviceaccording to one embodiment.

FIG. 33 is a timing diagram illustrating the steps of a vacuum-assistedbiopsy procedure according to one embodiment.

FIG. 34 is a table summarizing the steps of the vacuum-assisted biopsyprocedure illustrated in FIG. 33.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise. Asused in this specification, “reusable” devices and portions thereofinclude, but are not limited to, devices that are configured andintended to be used in multiple procedures. As used in thisspecification, “disposable” devices and portions thereof include, butare not limited to, devices that are configured and intended to be usedin only one procedure. After being used in a procedure, disposabledevices are configured and intended to be discarded. One differencebetween reusable and disposable medical devices is that contamination isa concern with the former but not the latter because disposable medicaldevices are not reused.

Various embodiments of the disclosed inventions are describedhereinafter with reference to the figures. It should be noted that thefigures are not drawn to scale. It should also be noted that the figuresare only intended to facilitate the description of the embodiments. Theyare not intended as an exhaustive description of the invention or as alimitation on the scope of the invention, which is defined only by theappended claims and their equivalents. In addition, an illustratedembodiment of the disclosed inventions needs not have all the aspects oradvantages shown. An aspect or an advantage described in conjunctionwith a particular embodiment of the disclosed inventions is notnecessarily limited to that embodiment and can be practiced in any otherembodiments even if not so illustrated. In order to better appreciatehow the above-recited and other advantages and objects are obtained, amore particular description of the embodiments will be rendered, whichare illustrated in the accompanying drawings. These drawings depict onlytypical embodiments of the disclosed inventions and are not therefore tobe considered limiting of its scope.

FIG. 1 depicts a biopsy device 10 in accordance with one embodiment. Thebiopsy device 10 includes a reusable body portion 12 and a disposableneedle portion 14. The reusable body portion 12 includes componentsconfigured to perform a tissue biopsy using the disposable needleportion 14. These components include a drive assembly configured todrive movement of components of the disposable needle portion 14. Anexemplary drive system is described in U.S. Provisional PatentApplication Ser. No. 62/055,610 [Attorney Docket No. 14.184011 PM],filed Sep. 25, 2014, and assigned to the same assignee as the instantapplication, the contents of which are incorporated by reference asthough fully set forth herein. The drive assembly can include one ormore motors known in the art, including electrical, pneumatic orhydraulic motors. The reusable body portion 12 also includes acontroller (e.g., a computer processor) configured to control the motorsin the drive assembly and thereby control movement of the components ofthe disposable needle portion 14.

Further, the reusable body portion 12 includes an elongate camconfigured to lock and unlock various components of the reusable bodyportion 12 in various modes of the biopsy procedure as described in theabove-incorporated patent application. In alternative embodiments, theelongate cam can have either: (1) grooves and slots for interacting withdetents or pegs; or (2) lobes or cams for interacting withstrike-plates. The interactions in both of these embodiments facilitatelocking and unlocking described above. These embodiments are describedin U.S. Provisional Patent Application Ser. No. 62/055,610 (incorporatedby reference above) and U.S. Utility patent application Ser. No.14/864,432 [Attorney Docket No. 14.184011 US1], filed concurrentlyherewith, and assigned to the same assignee as the instant application,the contents of which are incorporated by reference as though fully setforth herein. Elongate cams can include any elongated member comprisingfeatures configured to control movement of other device components, Forinstance, in other embodiments, the elongate cam can have both: (1)grooves and slots; and (2) lobes or cams.

FIGS. 2 and 3 depict respective distal portions of the disposable needleportion 14. FIG. 2 shows the outer cannula 16 without the inner cannula26. FIG. 3 shows the outer cannula 16 with a distal portion of the innercannula 26 visible through a tissue receiving opening 20. The disposableneedle portion 14 includes an outer cannula 16 having a distal tissuepiercing tip 18. The outer cannula defines an outer cannula lumen 24 andthe tissue receiving opening 20 adjacent to the distal tissue piercingtip 18, the tissue receiving opening 20 being in fluid communicationwith the outer cannula lumen 24. A biopsy device 10 having a variablesize tissue receiving opening 20 is described in U.S. patent applicationSer. No. 14/497,046 [Attorney Docket No. 14.185011 US1], filed Sep. 25,2014, and assigned to the same assignee as the instant application, thecontents of which are incorporated by reference as though fully setforth herein. In the disposable needle portion 14, the inner cannula 26is slidably disposed in the outer cannula lumen 24 and has an opendistal end 28 surrounded by an annular cutting blade 30 (FIG. 3). Whenthe inner cannula 26 is in its distal-most position in the outer cannulalumen 24, the inner cannula 26 closes the tissue receiving opening 20 inthe outer cannula 16.

As shown in FIGS. 4 and 5, a cutting board 22 is disposed in the outercannula lumen 24 distal to the tissue receiving opening 20. The cuttingboard 22 is configured to seal the open distal end 28 of the innercannula 26 when the inner cannula 26 is in contact with the cuttingboard 22. This seal prevents fluids introduced into the outer cannulalumen 24 from being aspirated through the open distal end 28 and theinner cannula lumen 32, and bypassing the biopsy site. Instead, thefluids are delivered to the tissue through the outer cannula lumen 24and the tissue receiving opening 20.

FIGS. 6 and 7 are axial cross-sectional views through respectiveportions of the outer and inner cannulas 16, 26 with other components ofthe disposable needle portion 14 omitted for clarity. As shown in FIGS.6 and 7, the outer and inner cannulas 16, 26 form an annular lumen 34there between. The annular lumen 34 is the portion of the outer cannulalumen 24 that is not occupied by the inner cannula 26. The outer cannula16 also defines two side openings 36 in communication with the annularlumen 34.

FIG. 8 depicts the biopsy device 10 with the top housing of thedisposable needle portion 14 omitted to facilitate visualization of theaspiration and irrigation system 38 relative to other components of thedisposable needle portion 14. FIG. 9 depicts the disposable needleportion 14 of a biopsy device 10 from a bottom view to facilitatevisualization of the aspiration and irrigation system 38 therein.

As shown in FIGS. 10 and 11, the aspiration and irrigation system 38includes an aspiration vent 40 fluidly coupled to an aspiration line 42and an irrigation input 44 fluidly coupled to an irrigation line 46. Theaspiration line 42 and irrigation line 46 are each in turn fluidlycoupled to a manifold 48. As shown in FIGS. 12 and 13, the manifold 48is in turn fluidly coupled to the side openings 36 in the outer cannula16, which lead to the annular lumen 34 therein.

FIGS. 14 to 18, 29 and 30 depict the aspiration and irrigation system 38and the outer and inner cannulas 16, 26 with all other components of thedisposable needle portion 14 of the biopsy device 10 omitted forclarity. FIGS. 14 and 15 depict the aspiration and irrigation system 38and the outer and inner cannulas 16, 26 in respective bottom andperspective wide views. In FIG. 15, the aspiration and irrigation system38 is shown in phantom for clarity. FIG. 29 is an axial cutaway view ofthe aspiration and irrigation system 38 and the outer and inner cannulas16, 26 at the level where the aspiration and irrigation lines 42, 46join the manifold 48. FIG. 30 is a longitudinal cutaway view of theaspiration and irrigation system 38 and the outer and inner cannulas 16,26 at the level of the outer and inner cannula lumens 24, 32. As shownin FIGS. 29 and 30, the manifold 48 is a space including a cylindricalportion 82 in fluid communication with the lumens of the aspiration andirrigation lines 42, 46 at a “T” junction. The manifold 48 also includesan annular portion 84 in fluid communication with the cylindricalportion 82, and therefore with the lumens of the aspiration andirrigation lines 42, 46. The annular portion 84 is disposed around andapproximately coaxial with portions of the outer and inner cannulas 16,26 and the annular lumen 34 therebetween.

FIGS. 16 and 17 depict the side opening 36 in the outer cannula 16 withthe manifold 48 shown in phantom illustrate the fluid coupling of themanifold 48 with the side opening 36. FIG. 18 is an axial cutaway viewthrough the manifold 48 and the outer and inner cannulas 16, 26 at theaxial position of the side opening 36. FIG. 18 illustrates the fluidcoupling of the manifold 48 with the annular lumen 34 via the sideopenings 36.

FIGS. 19 and 20 detailed longitudinal cross-sectional views through theouter and inner cannulas 16, 26 at the axial position of the sideopening 36. The views in FIGS. 19 and 20 are not perpendicular to thelongitudinal axis of the outer and inner cannulas 16, 26 in order toillustrate curvature of side opening 36. All other components of thedisposable needle portion 14 of the biopsy device 10 are omitted forclarity. FIGS. 19 and 20 depict the annular lumen 34 between the outerand inner cannulas 16, 26. They also depict the communication of theannular lumen 34 with the side openings 36 in the outer cannula 16.

FIG. 21 depicts an aspiration vent 40 according to one embodiment, withportions thereof shown in phantom to facilitate depiction of internalcomponents. In FIG. 21, the distal end of the biopsy device is pointedto the right of the figure. The aspiration vent 40 includes check andaspirate valves 50, 52, which are configured to close the aspirationvent 40 during vacuum-mediated and pressure-mediated irrigation,respectively (described below).

The check valve 50 includes an interference member 54 a disposed in achamber 62 a adjacent an upwardly-facing opening 58 of an interferencemember seat 56 a. The upwardly-facing opening 58 fluidly connects theaspiration line 42 to the atmosphere through the aspirate valve 52. Thedepicted interference member 54 a is spherical, and the depictedupwardly-facing opening 58 is circular. However, in other embodiments,the interference member 54 a and upwardly-facing opening 58 can have anyrespective complementary shapes. When the biopsy device 10 is mounted inposition for biopsy, the interference member 54 a sits in theinterference member seat 56 a and partially seals the upwardly-facingopening 58. The interference member 54 a is forced distally into theinterference member seat 56 a when liquid is delivered under pressurethrough the irrigation input 44 and irrigation line 46 because the checkvalve is fluidly connected to the irrigation line 46 through themanifold 48. Accordingly, when liquid is delivered under pressurethrough the irrigation input 44 and irrigation line 46, the seal in thecheck valve 50 is strengthened and becomes substantially fluid-tight.The seal in the check valve 50 facilitates delivery of liquid from theirrigation input 44 and irrigation line 46, through the manifold 48,side openings 36 and annular lumen 34, and out the tissue receivingopening 20 when the inner cannula lumen 32 is sealed by the cuttingboard 22 (described below). Examples of liquids that may be deliveredunder pressure include anesthetics, which may be injected into theirrigation input 44 by a syringe (not shown).

Like the check valve 50, the aspirate valve 52 includes an interferencemember 54 b disposed in a chamber 62 b adjacent an interference memberseat 56 b. However, the interference member seat 56 b in the aspiratevalve 52 has a side-facing opening 64 instead of an upwardly-facing one.The side-facing opening 64 connects the aspiration line 42 to theatmosphere through the check valve 50 and the aspirate valve 52. Thechamber 62 b of the aspirate valve 52 also includes a longitudinalopening 76 to facilitate actuation of the aspirate valve 52 (describedbelow). The depicted interference member 54 b is spherical, and thedepicted side-facing opening 64 is circular. However, in otherembodiments, the interference member 54 b and side-facing opening 64 canhave any respective complementary shapes. The chamber 62 b also includesa side-facing atmospheric opening 66 that opens into the interior of thedisposable needle portion 14 of the biopsy device 10, which is in turnopen to the atmosphere through small openings (not shown) in the housingof the disposable needle portion 14 of the biopsy device 10.Accordingly, the aspiration and irrigation system 38 and the disposableneedle portion 14 of the biopsy device 10 selectively communicate withthe atmosphere through the atmospheric opening 66 in the aspirate valve52.

When the biopsy device 10 is mounted in position for biopsy, and beforevacuum is applied, gravity causes the interference member 54 b to sit onthe bottom of the chamber 62 b of the aspirate valve 52, and does notseal the interference member seat 56 b therein. During vacuum-assistedbiopsies, a vacuum source (not shown) is connected to the proximal endof the inner cannula 26 while the distal end 28 of the inner cannula 26is retracted proximally from the cutting board 22, thereby facilitatingfluid communication between the vacuum source and the inner cannulalumen 32. When the vacuum source is connected to the aspiration andirrigation system 38, the vacuum pulls the interference member 54 b inthe aspirate valve 52 into the side-facing opening 64 with sufficientforce to substantially close the side-facing opening 64 in the aspiratevalve 52. Further, the vacuum also pulls the interference member 54 a inthe check valve 50 away from the upwardly-facing opening 58, therebyunblocking the upwardly-facing opening 58. Alternatively, chamber 62 bmay be configured to (e.g., have elastic walls that are biased to) causeinterference member 54 b to seal the side-facing opening 64, even in theabsence of vacuum, unless the seal is broken by peg 74. In suchembodiments, the chamber 62 b may not include a seating member.

When the vacuum source is connected to the aspiration and irrigationsystem 38, the vacuum also pulls liquid from an irrigation source (notshown) connected to the irrigation input 44. Examples of such liquidsinclude saline. With the aspirate valve 52 closed by the interferencemember 54 b, the liquid from the irrigation source travels throughirrigation input 44, the irrigation line 46, the manifold 48, the sideopenings 36 and the annular lumen 34 to enter the inner cannula lumen32, thereby facilitating transport of excise tissue through the innercannula 26 (described below). The use of fluids to facilitate tissuetransport during a biopsy procedure is described in U.S. patentapplication Ser. No. 13/383,318, [Attorney Docket No. 14.175011 US] U.S.National entry filed on Jan. 10, 2012 of PCT/US2011/062148 withinternational filing date Nov. 24, 2011, and assigned to the sameassignee as the instant application, the contents of which areincorporated by reference as though fully set forth herein. In otherembodiments, a saline valve (e.g., a pinch valve; not shown) may beprovided to additionally control the flow of liquid through the system38. For instance, the saline valve may be disposed in the biopsy consoledownstream of the saline source.

FIG. 22 depicts an actuation mechanism 68 configured to selectively openthe aspirate valve 52 of the aspiration vent 40 when a vacuum source isconnected to the aspiration and irrigation system 38. The actuationmechanism 68 includes an elongated cam 60, a vertical cam follower 70, adeflection surface 72, and a horizontal peg 74. The cam 60 has a distalend 80 in contact with the vertical cam follower 70, which is in contactwith the deflection surface 72. The deflection surface 72 is coupled tothe horizontal peg 74. In other embodiments, the deflection surface 72may be in contact with, rather than coupled to, the horizontal peg 74.The deflection surface 72 is approximately diagonal to both the verticalcam follower 70 and the horizontal peg 74. Accordingly, vertical motionby the cam follower 70 is transformed to horizontal motion of the peg74. The deflection surface 72 is an extension of the frame of thedisposable needle portion 14 of the biopsy device 10 and it is formedfrom an elastic material. As such, the deflection surface 72 and peg 74attached thereto are biased away from a longitudinal opening 76 and theinterference member 54 b of the aspirate valve 52. The cam follower 70is disposed in a lumen of a spring 78, which biases the cam followertoward the cam distal end 80 and away from the deflection surface 72.

The cam 60 and a method of controlling movement of various components ofthe biopsy device 10, including the interference member 54 b of theaspirate valve 52, by rotating the cam 60 are described in detail inU.S. Provisional Patent Application Ser. No. 62/055,610, which has beenpreviously incorporated by reference. By also using the cam 60 toactuate the aspirate valve 52, the number of parts and the size of thereusable body portion 12 is minimized. To actuate the aspirate valve 52,the peg 74 of the actuation mechanism 68 enters the chamber 62 b of theaspirate valve 52 through the longitudinal opening 76 to dislodge theinterference member 54 b from the interference member seat 56 b.

The actuation mechanism 68 includes components of both the reusable bodyportion 12 and disposable needle portion 14 of the biopsy device 10. Theelongated cam 60 and the vertical cam follower 70 are parts of thereusable body portion 12 of the biopsy device 10. The deflection surface72 and the horizontal peg 74 are parts of the disposable needle portion14 of the biopsy device 10. The vertical cam follower 70 extendsvertically out of the reusable body portion 12, and enters a bottomsurface of the disposable needle portion 14 to interact with thehorizontal peg 74 via the deflection surface 72. This arrangementminimizes the possibility of contamination of the patient because airentering the aspiration and irrigation system 38 through atmosphericopening 66, when aspirate valve 52 is open, passes over sterilecomponents in the disposable needle portion 14 rather than the cleancomponents in the reusable body portion 12. Because the clean verticalcam follower 70 only contacts the deflection surface 72, which isseparated from the sterile interference member 54 of the aspirate valve52 by the sterile horizontal peg 74, the possibility of contamination ofthe patient is substantially minimized.

FIG. 23 is a cutaway view through the reusable body portion 12 anddisposable needle portion 14 of the biopsy device 10 from anapproximately axial direction, with certain components omitted and thevertical cam follower 70 shown in phantom for clarity. The distal end 80of the elongate cam 60, which is configured to interact with the camfollower 70, is shaped like an eccentric wheel, thereby facilitating thecam distal end's 80 function of transforming rotary motion into linearmotion. The cam distal end 80, like all eccentric wheels, has a surfacediameter between a largest diameter and a smallest diameter.

FIG. 24 is a perspective view of the biopsy device 10 with certaincomponents omitted to show the juxtaposition of the interference member54 b of the aspirate valve 52 and the horizontal peg 74. FIGS. 25 to 28are cutaway views of the biopsy device 10, through axial planes thatmove distally along the longitudinal axis of the biopsy device 10, withcertain components omitted to show the interaction between thecomponents of the actuation mechanism 68 and the aspirate valve 52. FIG.27 illustrates the interaction between the cam 60, the cam follower 70and the deflection surface 72. FIG. 28 illustrates the interactionbetween the peg 74 and the interference member 54 b in the aspiratevalve 52. In FIGS. 22 to 28, the cam 60 is rotated such that thesmallest diameter surface of the cam distal end 80 is in contact withthe cam follower 70. As such, the cam follower 70 is biased in itslowest position by the spring 78 and the horizontal peg 74 is biasedaway from the interference member 54 b in the aspirate valve 52.

When the cam 60 is rotated such that the largest diameter surface of thecam distal end 80 is in contact with cam follower 70. Rotating the cam60 (and the cam distal end 80) into this position overcomes theexpansive force of the spring 78, and pushes the cam follower 70 up intothe deflection surface 72. The deflection surface 72 translates thevertical motion of the cam follower 70 into horizontal motion of thehorizontal peg 74. Horizontal motion of the peg 74 brings it intocontact with the interference member 54 b in the aspirate valve 52.Continued horizontal motion of the peg 74 dislodges the interferencemember 54 b from the side-facing opening 64 in the interference memberseat 56 b in the aspirate valve 52, thereby allowing the site-facingopening 64 to communicate with the atmosphere through the atmosphericopening 66 in the aspirate valve 52. Because the aspirate valve 52 isconnected to the inner cannula lumen 32 via the aspiration andirrigation system 38, when the cam 60 is rotated to dislodged theinterference member 54 b in the aspirate valve 52, a vacuum generated inthe inner cannula lumen 32 (e.g., by a vacuum source) is released/ventedby communication with the atmosphere through the aspiration vent 40.

Having described the structure of various components of the biopsydevice 10, including the aspiration interrogation system 38 and theactuation mechanism 68, a biopsy procedure 100 using the biopsy device10 will now be described. FIG. 31 summarizes the steps of avacuum-assisted biopsy procedure 100 according to one embodiment. Thesummary in FIG. 31 also includes the states of the check and aspiratevalves 50, 52 and various irrigation and aspiration/venting relatedfunctions at the respective steps. The steps summarized in FIG. 31 canbe in addition to the biopsy procedure 100 that is described in detailin U.S. Provisional Patent Application Ser. No. 62/055,610, which hasbeen previously incorporated by reference.

At step 102, a user (e.g., a physician and/or a technician working underthe direction of a physician) mounts the biopsy device 10 to a stablesurface like a stereotactic surgical table. When the biopsy device 10 isfirst mounted, the inner cannula 26 is in its distal most location, withits distal end 28 against the cutting board 22 in the outer cannulalumen 24. Further, the vacuum is off and no liquid is introduced intothe aspiration and irrigation system 38 under pressure. As such, thecheck and aspirate valves 50, 52 are open and venting is possible.However, because the vacuum is off, there is no vacuum to vent.

Before step 104, distal portions of the outer and inner cannulas 16, 26have already been inserted into the tissue to be biopsied. At step 104,a liquid (e.g., saline and/or anesthesia) is delivered to the tissueadjacent the tissue receiving opening 20 in the outer cannula 16. Thedelivered liquid can also travel in a retrograde fashion along the pathof the outer cannula 16 ultimately into the tissue, where anesthetic canrelieve pain associated with the procedure. At step 104, the vacuumremains in an off position, therefore the aspirate valve 52 remainsopen. At step 104, the inner cannula 26 is still in its distal mostlocation against the cutting board 22. Accordingly, when the liquid isdelivered through the irrigation input 44 and the irrigation line 46under pressure (by using a syringe), the liquid cannot enter the innercannula lumen 32. Further, the liquid cannot exit the aspiration andirrigation system 38 through the aspiration vent 40 because the checkvalve 50 is closed by the liquid under pressure. Therefore, the liquidexits the outer cannula lumen 24 via the only open exit, i.e., thetissue receiving opening 20, and flows into the tissue as describedabove.

At step 106, the inner cannula 26 remains in its distal most locationagainst the cutting board 22. However, the introduction of pressurizedliquid into the aspiration and irrigation system 38 via the irrigationinput 44 at step 104 is terminated. As a result, the check valve 50opens, and remains open from step 106 to step 116. Further, the vacuumsource is turned on and delivers vacuum to the inner cannula 26, andremains on from step 106 to step 116. However, because the distal end 28of the inner cannula 26 is blocked by the cutting board 22 in step 106,the vacuum source is not in fluid communication with the aspiration andirrigation system 38 via the outer cannula 16. As a result, although theaspirate valve 52 remains open, venting does not occur to anysubstantial degree. Moreover, with a lack of pressure and vacuum in theaspiration and irrigation system 38, liquid flow through the system 38is minimal to none.

At step 108, the inner cannula 26 begins moving proximally away from thecutting board 22 to prepare for the first cutting stroke, therebyexposing its open distal end 28, and fluidly connecting the innercannula lumen 32 to the annular lumen 34. Because the vacuum sourceremains on and connected to the inner cannula 26, the vacuum closes theaspirate valve 52 as described above. Because the aspirate valve 52 isclosed, the vacuum is not vented. Because there is no pressurized fluidentering the irrigation input 44, the check valve 50 remains open.Because the aspirate valve 52 is closed, vacuum from the vacuum sourcepulls liquid (i.e., saline) through the irrigation input 44 (and not airthrough the aspirate valve), the irrigation line 46, the manifold 48,side openings 36, the annular lumen 34, and into the inner cannula lumen32 through the open distal end 28 thereof. Since step 108 precedes thefirst cutting stroke, there is no excised tissue in the inner cannulalumen 32. Therefore, the liquid entering the aspiration and irrigationsystem 38 through the irrigation input 44 flows through the innercannula lumen 32 unobstructed.

At step 110, the inner cannula has reached its proximal most location,and the first cutting stroke and is ready to begin. As in step 108, thevacuum source remains powered on and connected to the inner cannula 26,the aspirate valve 52 remains closed, the check valve 50 remains open,the vacuum is not vented, and thus liquid flows under vacuum. Before thefirst cutting stroke, there still is no excised tissue in the innercannula lumen 32. Therefore the liquid continues to flow through theinner cannula lumen 32 unobstructed.

The cutting stroke starts at step 112, when the inner cannula begins tomove distally from its proximal most location. As in steps 108 and 110,the vacuum source remains powered on and connected to the inner cannula26, the aspirate valve 52 remains closed, the check valve 50 remainsopen, the vacuum is not vented, and thus liquid flows under vacuum fromthe irrigation input 44 to the inner cannula lumen 32. Step 112 is thecutting portion of the cutting cycle, during which the inner cannula 26moves distally from its proximal most location to its distal mostlocation. Excised tissue that is no longer connected to the rest of thetissue will be drawn proximally through the inner cannula lumen 32 bythe vacuum source. The liquid flowing from the aspiration and irrigationsystem 38 facilitates transport of excised tissue. During step 112, theinner cannula 26 rotates as it translates distally to facilitate cuttingof tissue.

At step 114, the biopsy device 10 has reached the approximate middle ofthe cutting cycle, when the inner cannula 26 reaches its distal mostlocation against the cutting board 22. At that point, the inner cannula26 terminates its axial movement, but continues to rotate to facilitatecutting of tissue. As in steps 108 to 112, the vacuum source remainspowered on and connected to the inner cannula 26 and the check valve 50remains open. However, because the distal end 28 of the inner cannula 26is closed by the cutting board 22, the aspirate valve 52 is open.Further, the vacuum in the inner cannula lumen 32 is not vented becauseit is sealed off from the aspiration vent 40 by the cutting board 22.Moreover, because the vacuum does not reach the aspiration andirrigation system 38, liquid flow through the system 38 is minimal tonone. Step 114 is similar to step 106 described above.

At step 116, the inner cannula is on the second half, i.e., theretracting portion, of the cutting cycle, during which the inner cannula26 moves proximally from its distal most position to its proximal mostposition. During step 116, the excised tissue is separated from the restof the target site and is moved proximally through the inner cannulalumen 32 under vacuum. As in steps 108 to 114, the vacuum source remainspowered on and connected to the inner cannula 26 and the check valve 50remains open. However, at step 116, the elongate cam 60 is rotated suchthat the vertical cam followers 70 rises, causing the horizontal peg 74to move into the chamber 62 b of the aspirate valve 52 to therebydislodge the interference member 54 b from the interference member seat56 b. Dislodging the interference member 54 b opens the aspirate valve52 and allows vacuum distal of the excised tissue in the inner cannulalumen 32 to vent to atmosphere through the aspiration and irrigationsystem 38. In step 114, liquid flow through the aspiration andirrigation system 38 is minimal to none because the vacuum is beingvented through the system 38. In one embodiment, a controller in thebiopsy device 10 activates a motor that rotates the elongate cam 60 toopen the aspirate valve 52. The inner cannula 26 continues to rotateduring step 116.

Venting the vacuum distal of the excised tissue increases the pressureimbalance proximal and distal of the excised tissue, thereby increasingthe rate at which the excised tissue travels through the inner cannulalumen 32. Increasing the pressure imbalance also prevents excised tissuefrom becoming trapped in the inner cannula lumen 32 due to increasingvacuum distal of the excised tissue that cannot be vented.

After step 116, steps 114 to 116 can be repeated until the biopsy iscompleted. While the biopsy procedure 100 described above includes“turning on and connecting” a vacuum source, the vacuum source may bepermanently turned on and selectively connected to and disconnected fromthe inner cannula lumen 32 at the appropriate steps in the procedure.

In an alternative embodiment, the aspiration vent 40 is located in thereusable body portion 12 of the biopsy device 10. In such embodiments, afilter in the disposable needle portion 14 would prevent liquids fromentering the aspiration vent 40 in the reusable body portion 12.Therefore, the filter prevents contamination of the reusable bodyportion 12. After each biopsy, the filter would be disposed of alongwith the disposable needle portion 14. In one embodiment, the filter is0.22 μm or smaller to prevent contamination of the reusable body portion12.

In another alternative embodiment, the aspirate valve 52 can be actuatedvia the dwell spring, which is described in detail in U.S. ProvisionalPatent Application Ser. No. 62/055,610, which has been previouslyincorporated by reference. A lever or cam can be driven by retraction ofthe dwell spring mechanism to actuate open the aspirate valve 52.Actuating the aspirate valve 52 via the dwell spring would mechanicallylink the venting of vacuum distal of excised tissue in the inner cannulalumen 32 with retraction of the inner cannula 26 after each cuttingstroke. In yet another alternative embodiment, the aspirate valve 52 canbe actuated via a solenoid that is controlled by the biopsy devicecontroller.

In still another alternative embodiment, the cylinder surrounding theside opening 36 in the outer cannula 16 and fluidly coupled to themanifold 48 can be increased in size to increase the rate of liquid flowthrough the aspiration and irrigation system 38.

FIG. 32 is a system diagram schematically depicting a vacuum-assistedbiopsy device 200 according to another embodiment. The biopsy device 200depicted in FIG. 32 is almost identical to the biopsy device 10described above, except that the biopsy device 200 depicted in FIG. 32includes a liquid valve 286 (e.g., a pinch valve) disposed between aliquid source 288 and a manifold 248. The liquid valve 286 can also becalled a saline valve 286. As in the biopsy device 10 described above,the manifold 248 in FIG. 32 is also fluidly coupled to an annular lumen234 and an air valve 250, 252, which is for aspiration to atmosphere292. The air valve 250, 252 includes a check valve 250 and an aspiratevalve 252, which are similar to respective check valve 50 and aspiratevalve 52 described above with respect to biopsy device 10.

While this embodiment includes a liquid valve/saline valve 286, biopsydevices according to other embodiments do not include a liquidvalve/saline valve. In such embodiments, liquid/saline flow may becontrolled by positive pressure and vacuum in the system.

FIG. 32 depicts air and liquid flow in the biopsy device 200. The vacuumsource 290 is fluidly coupled to a proximal end of the inner cannulalumen 232, which is in turn, selectively fluidly coupled to the annularlumen 234 (defined between inner and outer cannulas, not shown). Theannular lumen 234 is fluidly coupled at the proximal end to the tissuereceiving opening 220, which leads outside of the distal end of theouter cannula (not shown) and at the distal end to the manifold 248. Themanifold 248 is selectively fluidly coupled to the liquid source 288(via liquid valve 286) and atmosphere 292 (air valve 250, 252). Whilethere is no “valve” between the inner cannula lumen 232 and the annularlumen 234, these two lumens 232, 234 are only fluidly coupled to eachother when the inner cannula 226 is retracted proximally away from thecutting board 222.

FIG. 33 is a timing diagram illustrating the steps of a vacuum-assistedbiopsy procedure 300, according to another embodiment, using the biopsydevice 200 depicted in FIG. 32. FIG. 34 is a table 400 summarizing thesteps of the vacuum-assisted biopsy procedure 300 illustrated in FIG.33. Steps 1 to 6 represent one cutting cycle using the biopsy device200.

Step 1, i.e., “pre-cut vacuum,” follows completion of the previouscutting cycle, which concludes with a post-aspirate lavage. Thus Step 1begins with closing of the liquid valve 286 (e.g., at 13.5 s in FIG.33). In FIGS. 33 and 34, the liquid valve 286 is labeled “saline valve.”During Step 1, which lasts about 0.5 s, vacuum builds in the biopsydevice 200 thereby drawing tissue into tissue receiving opening 220.Step 1 concludes when the inner cannula is fully proximally retracted,the liquid valve 286 is closed, and the air valve 250, 252 is closed.

Step 2, i.e., “biopsy cut,” begins after completion of Step 1 (“pre-cutvacuum”). Optionally, Step 2 begins after receipt of a Core IndexComplete Message, in systems with indexing core collection chambers,such as those described in U.S. patent application Ser. No. 13/383,318,the contents of which are incorporated by reference as though fully setforth herein. During Step 2, which lasts less than 2 s (about 1.75 s inFIG. 33), the inner cannula 226 moves from the fully proximallyretracted position to the fully distally extended position whilerotating to cut tissue prolapsing through the tissue receiving opening220. Step 2 concludes just before the inner cannula 226 reversesrotation, the liquid valve 286 is closed and the air valve 250, 252 isclosed.

Step 3, i.e., “IC retraction,” begins when the inner cannula 226reverses rotation at the end of Step 2. During Step 3, which lasts lessthan 2 s (about 1.75 s in FIG. 33), the inner cannula 226 unwinds thedwell spring for about the first 0.25 s, and then retracts from thefully distally extended position to the fully proximally retractedposition while rotating in the reverse direction. The liquid valve 286is open during the first 0.5 s of Step 3 (see Step 4 below) and the airvalve 250, 252 is closed.

There is a dwell period that overlaps Steps 2 and 3, as described indetail in U.S. Provisional Patent Application Ser. No. 62/055,610, whichhas been previously incorporated by reference. During the dwell period,which lasts about 0.5 s, the inner cannula 226 is positioned at itsfully distally extended position against the cutting board 222, andcontinues to rotate (in the same direction as during the rest of Step 2)to completely sever the prolapsing tissue.

Step 4, i.e., “Pre-Aspirate Lavage,” which overlaps the first 0.5 s ofStep 3, is triggered by reversal of the motor that rotates the innercannula 226 at the end of Step 2. During Step 4, which lasts about 0.5s, the inner cannula 226 rotates and unwinds the dwell spring for aboutthe first 0.25 s, and then begins to retract from the fully distallyextended position in a proximal direction. The liquid valve 286 is openand the air valve 250, 252 is closed. Opening the liquid valve 286during Step 4 allows a bolus of liquid (e.g., saline) to be introducedinto the device 200. Because the air valve 250, 252 is closed, the bolusof liquid will travel through the manifold 248 and the annular lumen234, and fill in behind the severed tissue in the inner cannula lumen232. This liquid facilitates the vacuum assisted proximal travel of thetissue through the inner cannula lumen 232.

Step 5, i.e., “Aspiration,” is triggered by completion of Step 3 in thatStep 5 is programmed to begin about 2.0 s after completion of Step 3.During Step 5, which lasts at least 2 s (about 2 s in FIG. 33), theinner cannula 226 is at its fully proximally retracted position. Theliquid valve 286 is closed and the air valve 250, 252 is open. The airvalve may be opened by opening the aspirate valve 252 using an actuationmechanism as described above for the biopsy device 10 depicted in FIGS.21-28. Opening the air valve releases the vacuum distal of the severedtissue in the inner cannula lumen 232, thereby facilitating the vacuumassisted proximal travel of the tissue through the inner cannula lumen232.

Step 6, i.e., “Post-Aspirate Lavage,” is triggered by completion of Step5 in that Step 6 is programmed to begin about 0.25 s after completion ofStep 5. During Step 6, which lasts about 0.5 s, the inner cannula 226 isat its fully proximally retracted position. The liquid valve 286 is openand the air valve 250, 252 is closed. Opening the liquid valve 286during Step 6 allows another bolus of liquid (e.g., saline) to beintroduced into the device. Because the air valve 250, 252 is closed,the bolus of liquid will travel through the manifold 248 and the annularlumen 234, and into the inner cannula lumen 232. This liquid removesfrom the inner cannula lumen 232 any tissue remnants from the previousbiopsy stroke to prepare the device 200 for the next biopsy stroke.

After Step 6, the biopsy device 200 can cycle through Steps 1-6 tosequentially biopsy additional tissue samples. Although Steps 1-6 aredescribed above as having specific “triggers,” these descriptions areintended to be illustrative and not limiting. For instance, whileaspiration Step 5 is depicted in FIG. 34 as being “triggered” bycompletion of inner cannula retraction, the aspiration step can beprogrammed to begin at any time relative to an event in the biopsyprocedure 300, including a predetermined amount of time after an event(e.g., 0.5 s after liquid valve closes). Note that in the method 100depicted in FIG. 31 and previously described, the aspiration step isbegins at the same time that the inner cannula 26 begins to moveproximally from the distal most position.

While the embodiments described herein have a particular aspirationvalve structure, that structure is illustrative and not intended to belimiting. Accordingly, the actuating mechanism described herein can beused to open any suitable valve, including those without seatingmembers.

Although particular embodiments of the disclosed inventions have beenshown and described herein, it will be understood by those skilled inthe art that they are not intended to limit the present inventions, andit will be obvious to those skilled in the art that various changes andmodifications may be made (e.g., the dimensions of various parts)without departing from the scope of the disclosed inventions, which isto be defined only by the following claims and their equivalents. Thespecification and drawings are, accordingly, to be regarded in anillustrative rather than restrictive sense. The various embodiments ofthe disclosed inventions shown and described herein are intended tocover alternatives, modifications, and equivalents of the disclosedinventions, which may be included within the scope of the appendedclaims.

1. (canceled)
 2. A method of operating a biopsy apparatus, the biopsyapparatus comprising an instrument set configured for removable couplingwith an instrument drive unit, the instrument set comprising aninstrument set housing, an elongate outer cannula having an axial lumen,a proximal portion coupled to the instrument set housing, and a distalportion having a tissue receiving aperture in a side wall thereof incommunication with the lumen, an elongate inner cannula disposed withinthe outer cannula lumen, an aspiration vent fluidly coupling the outercannula lumen to atmosphere, and an aspirate valve interposed in theaspiration vent, the inner cannula having a lumen in fluid communicationwith the tissue receiving aperture in the outer cannula via a distalopening in the inner cannula, the method comprising: introducing thedistal portion of the biopsy apparatus in tissue so that the tissuereceiving aperture in the outer cannula is positioned adjacent thetissue targeted for biopsy; applying vacuum though a proximal end of theinner cannula lumen; translating the inner cannula relative to the outercannula to sever tissue prolapsed into the tissue receiving opening;translating the inner cannula proximally relative to the outer cannula;and opening the aspirate valve to draw air into the biopsy apparatusthrough the aspiration vent to relieve a vacuum formed distal of thesevered tissue.
 3. The method of claim 2, wherein the aspiration vent isfluidly coupled to a non-sealed interior of the instrument set housing.4. The method of claim 2, wherein, when the aspirate valve is open, theouter cannula lumen vents to the non-sealed interior of the instrumentset housing through the aspiration vent.
 5. The method of claim 2,further comprising removably coupling the instrument drive unit to theinstrument set, wherein the instrument drive unit selectivelymechanically opens the aspirate valve.
 6. The method of claim 2, whereinthe instrument set comprises an interference member, the method furthercomprising selectively mechanically actuating the interference member toprevent the aspirate valve from closing.
 7. The method of claim 2,wherein the instrument drive unit is removably coupled to the instrumentset, and wherein the instrument drive unit comprises an actuatingmember, the method further comprising the actuating member selectivelymechanically actuating the interference member.
 8. The method of claim7, wherein the actuating member comprises a cam that is rotatablycoupled to a drive unit support structure, the method further comprisingrotating the cam to selectively mechanically actuate the interferencemember.
 9. The method of claim 8, wherein the instrument drive unitfurther comprises a motorized cam driver having an output operativelycoupled to the cam for providing automatic rotation of the cam between afirst position, in which the cam does not actuate the interferencemember, and a second position, in which the cam actuates theinterference member.
 10. The method of claim 9, wherein the motorizedcam driver is processor controlled to selectively rotate the cam intoand out of the first position depending upon a respective position and adirection of travel of the inner cannula relative to the outer cannula.11. The method of claim 6, wherein the aspirate valve is configured suchthat the aspirate valve remains closed unless the interference member ismechanically actuated to prevent the aspirate valve from closing. 12.The method of claim 2, wherein the aspirate valve comprises a sealingmember configured to seal a valve opening when a vacuum is suppliedthrough the outer cannula, and a valve chamber, wherein the sealingmember is disposed in the valve chamber.
 13. The method of claim 12,wherein the drive unit support structure is configured for mounting to astereotactic table adapter, the sealing member comprising a ball, andthe valve chamber opening being located in a lateral sidewall of thevalve chamber such that, when the drive unit support structure ismounted to the adapter and the instrument set housing is coupled to theinstrument drive unit, the method further comprising, when the vacuum isapplied though the proximal end of the inner cannula lumen, the vacuumdrawing the ball against the valve chamber opening.
 14. The method ofclaim 2, wherein the aspirate valve is configured such that the aspiratevalve remains open unless the vacuum is supplied through the outercannula.
 15. The method of claim 2, wherein the outer cannula is movablerelative to the instrument set housing.
 16. A method of operating abiopsy apparatus, the biopsy apparatus comprising an instrument setconfigured for removable coupling with an instrument drive unit, theinstrument set comprising an instrument set housing, an elongate outercannula having an axial lumen, a proximal portion coupled to theinstrument set housing, and a distal portion having a tissue receivingaperture in a side wall thereof in communication with the lumen, anelongate inner cannula disposed within the outer cannula lumen, anaspiration vent fluidly coupling the outer cannula lumen to atmosphere,an aspirate valve interposed in the aspiration vent, and an interferencemember, the inner cannula having a lumen in fluid communication with thetissue receiving aperture in the outer cannula via a distal opening inthe inner cannula, the method comprising: introducing the distal portionof the biopsy apparatus in tissue so that the tissue receiving aperturein the outer cannula is positioned adjacent the tissue targeted forbiopsy; applying vacuum though a proximal end of the inner cannulalumen; translating the inner cannula relative to the outer cannula tosever tissue prolapsed into the tissue receiving opening; translatingthe inner cannula proximally relative to the outer cannula; opening theaspirate valve to draw air into the biopsy apparatus through theaspiration vent to relieve a vacuum formed distal of the severed tissue,wherein, when the aspirate valve is open, the outer cannula lumen ventsto the non-sealed interior of the instrument set housing through theaspiration vent; and selectively mechanically actuating the interferencemember to prevent the aspirate valve from closing.
 17. The method ofclaim 16, wherein the instrument drive unit is removably coupled to theinstrument set, and wherein the instrument drive unit comprises anactuating member, the method further comprising the actuating memberselectively mechanically actuating the interference member.
 18. Themethod of claim 17, wherein the actuating member comprises a cam that isrotatably coupled to a drive unit support structure, the method furthercomprising rotating the cam to selectively mechanically actuate theinterference member.
 19. The method of claim 18, wherein the instrumentdrive unit further comprises a motorized cam driver having an outputoperatively coupled to the cam for providing automatic rotation of thecam between a first position, in which the cam does not actuate theinterference member, and a second position, in which the cam actuatesthe interference member.
 20. The method of claim 19, wherein themotorized cam driver is processor controlled to selectively rotate thecam into and out of the first position depending upon a respectiveposition and a direction of travel of the inner cannula relative to theouter cannula.
 21. The method of claim 16, wherein the aspirate valve isconfigured such that the aspirate valve remains closed unless theinterference member is mechanically actuated to prevent the aspiratevalve from closing.